Recruiting
Phase 2

Givastomig & Nivolumab

Sponsor:

I-Mab Biopharma US Limited

Code:

NCT07432295

Conditions

Solid Tumor

Advanced Cancer

Metastatic Cancer

Gastric Cancer

Gastroesophageal Junction Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Givastomig

Nivolumab

5Fluorouracil

Leucovorin

Oxaliplatin

Study Details

Brief summary:

The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:

  • Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?
  • What toxicities do participants experience when taking givastomig?

Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.

Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.

Participants will:

  • Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks
  • Report any changes in their symptoms to their study doctors
  • Have scans to check for any changes in their cancer every 8-12 weeks

Conditions

Solid Tumor

Advanced Cancer

Metastatic Cancer

Gastric Cancer

Gastroesophageal Junction Carcinoma

Study ID

NCT07432295

Start date

Feb 11, 2026

Status verified date

May, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).
  • Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose).
  • CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).
  • PD-L1 positive (CPS ≥1).
  • At least 1 measurable lesion per RECIST v1.1.
  • ECOG performance status 0 or 1.
  • Adequate organ function, including:

  • Hematologic: WBC ≥2,000/μL; ANC ≥1,500/μL; platelets ≥100,000/μL; hemoglobin ≥9 g/dL
  • Hepatic: AST/ALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)
  • Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m²
  • Life expectancy ≥90 days.
  • Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.
  • Willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

  • HER2-positive tumors.
  • Second malignancy within 3 years, except certain skin or cervical cancers.
  • Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.
  • Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.
  • Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years.
  • Participation in another therapeutic clinical trial.
  • Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.
  • Radiotherapy within protocol-specified timeframes without adequate recovery.
  • Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).
  • Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA/stroke, or major cardiac procedures within 6 months).
  • Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).
  • Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.
  • Active infection requiring parenteral therapy.
  • Known hypersensitivity to study drug components (e.g., DPD deficiency).
  • Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Givastomig Arm 1 Combination

Givastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX

experimental: Experimental: Givastomig Arm 2 Combination

Givastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX

active comparator: Control: Nivolumab Plus Chemotherapy

Nivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX

Interventions

Givastomig

Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV

Nivolumab

Q2 or Q3W IV

5Fluorouracil

Q2W IV

Leucovorin

Q2W IV

Oxaliplatin

Q2W or Q3W IV

Capecitabine

Twice daily x 14 days every 3 weeks PO

Primary outcome measure

  • Progression-Free Survival (PFS), BICR-assessed [ Time Frame: Up to 5 years ]
  • Safety and Tolerability [ Time Frame: Throughout treatment and up to 30 days after last dose ]

Central Contacts and Locations

Central contacts

I-MAB US Clinical Trials

301-294-4408us.info@imabbio.com

Locations

I-Mab Site 1016

Recruiting

Goodyear, Arizona, United States, 85338

I-MAB Site 1005

Recruiting

Duarte, California, United States, 91010

I-Mab Site 1002

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

I-Mab Biopharma US Limited

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by I-Mab Biopharma US Limited on 2026-05-14.